FDA 510(k)

Portrait VSM

N.º K: K233810 · 2024-04-25

SolicitanteGe Medical Systems Information Technologies, Inc.

Fecha de decisión2024-04-25

Código de productoMWI

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Portrait VSM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2024-04-25 under 510(k) number K233810. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Portrait VSM?

Portrait VSM is a medical device that received FDA 510(k) clearance on 2024-04-25. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K233810.

When did Portrait VSM receive FDA 510(k) clearance?

Portrait VSM received FDA 510(k) clearance on 2024-04-25, under 510(k) number K233810.

Who is the listed applicant for Portrait VSM?

The FDA 510(k) record lists Ge Medical Systems Information Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portrait VSM?

The FDA product code for Portrait VSM is MWI.

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Otros registros que enlistan a Ge Medical Systems Information Technologies, Inc. como solicitante

K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P K251670MAC 7 Resting ECG Analysis System K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse O K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System

Ver todos los 21 dispositivos →

Dispositivos relacionados (Código: MWI)

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Fuente oficial

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